Neck PainNCT05393323
Effects of Cervical Distraction Versus Cervical Traction Techniques on Upper Cervical Pain
A study testing conventional physical therapy with distraction technique and conventional physical therapy with traction technique in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- conventional physical therapy with distraction technique and conventional physical therapy with traction technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Minimum 3 months chronicity of upper cervical pain
- Positive flexion-rotation test (asymmetry of >10◦ between sides or less than 32◦ in any direction)
- hypomobility in one or more segments of C0-1, C1-2, or C2-3
Who cannot join
- Congenital abnormalities (Cervical torticollis)
- Past surgical history of cervical spine
- Any history of neck trauma
- Already undergone physiotherapy treatment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mehmooda begum medical complex
Faisalābad, Punjab Province, 54000
About this study
Official title: Effects of Cervical Distraction Versus Cervical Traction Techniques on Pain, Range of Motion and Function in Patients With Upper Cervical Pain
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive cervical distraction technique with conventional physical therapy while Group B will receive cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25
Read the detailed description
The term collectively used for musculoskeletal conditions originating from cervical area is known as neck pain. According to the Global burden of disease (2010) study, neck pain is the fourth agent which is the reason behind chronic disability. The incidence of cervical pain in the adult population aged 15 to 74 years is 5.92% to 38.7% and it is more prevalent in women than men. The best predictor of future neck pain is the presence of an episode of neck pain in the past. Cervical rotation deficits are noted mostly in upper cervical spine issues as in atlantoaxial joint pathology.
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be a randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive the cervical distraction technique with conventional physical therapy while Group B will receive the cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25.
- Conditions
- Neck Pain
- Being tested
- conventional physical therapy with distraction technique, conventional physical therapy with traction technique
- Keywords
- Cervical pain, Traction, Distraction
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapy with distraction techniqueOther
Distraction will be at suboccipital level and patients will ask to assume a supine position with the head on the plinth. The therapist will use fingertips in both hands from digits 2 through 5, and cups the suboccipital region of the patient and supports the posterior skull. The therapist provides a light distraction to the posterior skull. Distraction will be applied for 10 min with pull for 10 sec and5 sec will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 minute with total intervention period of 4 weeks with 5 sessions per week.
conventional physical therapy with traction techniqueOther
In cervical traction, patients will ask to lie supine on the treatment table. Head will cradle by physiotherapist from chin and the occiput, and then the physiotherapist will apply traction force in 25 degree neck flexion. Traction will be applied for 10 minutes with pull for 10 sec and 5 sec rest will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 min with total intervention period of 4 weeks with 5 sessions per week. All outcome measurements will be assessed before treatment and then reassessed at the end of 4th week.
| Study group | Role | What they receive |
|---|---|---|
| Distraction technique | Experimental | conventional physical therapy with distraction technique Receives: Other: conventional physical therapy with distraction technique |
| Traction technique | Experimental | conventional physical therapy with traction technique Receives: Other: conventional physical therapy with traction technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
Measured: 4th week
NDI
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
Measured: 4th Week
Goniometric measurement
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393323
- Sponsor's protocol ID
- REC/RCR & AHS/0136 Hafsa Khan
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaishy S, Kondal S. Effect of Vertical Cervical traction Combined with Conventional Neurodynamic Mobilization and SNAGs in an Individual with Neck Pain and Cervical Radiculopathy: A Case Report.
Khan K, Yasmeen S, Ishaque F, Imdad F, Shaikh SA, Nawaz U, et al. A RANDOMIZED CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY OF MANUAL TRACTION ON PAIN AND RANGE OF MOTION IN CERVICAL RADICULOPATHY.
Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
PubMed 32035569Windsor RE, Malanga G, Benjamin M, Chawla J. Cervical spine anatomy. Medscape; 2017.
Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
PubMed 29480409Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
PubMed 32864219Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
PubMed 28750310Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
PubMed 34900443Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.
PubMed 32927858Afzal R, Ghous M, Shakil Ur Rehman S, Masood T. Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. J Pak Med Assoc. 2019 Sep;69(9):1237-1241.
PubMed 31511705
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Distraction Versus Cervical Traction Techniques on Pain, Range of Motion and Function in Patients With Upper Cervical Pain
- ClinicalTrials.gov ID
- NCT05393323
- Acronym / sponsor ID
- REC/RCR & AHS/0136 Hafsa Khan
- Conditions
- Neck Pain
- Keywords
- Cervical pain, Traction, Distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive cervical distraction technique with conventional physical therapy while Group B will receive cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25
Detailed description
The term collectively used for musculoskeletal conditions originating from cervical area is known as neck pain. According to the Global burden of disease (2010) study, neck pain is the fourth agent which is the reason behind chronic disability. The incidence of cervical pain in the adult population aged 15 to 74 years is 5.92% to 38.7% and it is more prevalent in women than men. The best predictor of future neck pain is the presence of an episode of neck pain in the past. Cervical rotation deficits are noted mostly in upper cervical spine issues as in atlantoaxial joint pathology.
The aim of this study is to compare the effects of cervical distraction versus cervical traction techniques on pain, range of motion and function in patients with upper cervical pain. This study will be a randomized clinical trial and 42 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A will receive the cervical distraction technique with conventional physical therapy while Group B will receive the cervical traction technique with conventional therapy. Outcome measures; Neck Disability Index, goniometry and Numeric Pain Rating Scale will measure neck function and neck pain intensity. Both groups will receive 5 sessions per week for 4 weeks and measurements will be taken at the baseline and at the end of 4th week. Data will be analyzed by SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction technique | Experimental | Other: conventional physical therapy with distraction techniqueconventional physical therapy with distraction technique |
| Traction technique | Experimental | Other: conventional physical therapy with traction techniqueconventional physical therapy with traction technique |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Minimum 3 months chronicity of upper cervical pain
- Positive flexion-rotation test (asymmetry of >10◦ between sides or less than 32◦ in any direction)
- hypomobility in one or more segments of C0-1, C1-2, or C2-3
Key exclusion criteria (4 listed)
- Congenital abnormalities (Cervical torticollis)
- Past surgical history of cervical spine
- Any history of neck trauma
- Already undergone physiotherapy treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physical therapy with distraction techniqueDistraction will be at suboccipital level and patients will ask to assume a supine position with the head on the plinth. The therapist will use fingertips in both hands from digits 2 through 5, and cups the suboccipital region of the patient and supports the posterior skull. The therapist provides a light distraction to the posterior skull. Distraction will be applied for 10 min with pull for 10 sec and5 sec will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 minute with total intervention period of 4 weeks with 5 sessions per week. | Other | Distraction technique |
| conventional physical therapy with traction techniqueIn cervical traction, patients will ask to lie supine on the treatment table. Head will cradle by physiotherapist from chin and the occiput, and then the physiotherapist will apply traction force in 25 degree neck flexion. Traction will be applied for 10 minutes with pull for 10 sec and 5 sec rest will be applied. Prior to apply this technique all patients will receive 15 minutes of infrared with TENS at cervical spine. The total treatment session will be of 25 min with total intervention period of 4 weeks with 5 sessions per week. All outcome measurements will be assessed before treatment and then reassessed at the end of 4th week. | Other | Traction technique |
Primary outcome
NPRS
Time frame: 4th week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain
NDI
Time frame: 4th Week
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
Goniometric measurement
Time frame: 4th Week
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- BackgroundVaishy S, Kondal S. Effect of Vertical Cervical traction Combined with Conventional Neurodynamic Mobilization and SNAGs in an Individual with Neck Pain and Cervical Radiculopathy: A Case Report.
- BackgroundKhan K, Yasmeen S, Ishaque F, Imdad F, Shaikh SA, Nawaz U, et al. A RANDOMIZED CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY OF MANUAL TRACTION ON PAIN AND RANGE OF MOTION IN CERVICAL RADICULOPATHY.
- Background: PubMed 32035569Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.
- BackgroundWindsor RE, Malanga G, Benjamin M, Chawla J. Cervical spine anatomy. Medscape; 2017.
- Background: PubMed 29480409Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
- Background: PubMed 32864219Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
- Background: PubMed 28750310Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
- Background: PubMed 34900443Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
- Background: PubMed 32927858Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.
- Background: PubMed 31511705Afzal R, Ghous M, Shakil Ur Rehman S, Masood T. Comparison between Manual Traction, Manual Opening technique and Combination in Patients with cervical radiculopathy: Randomized Control Trial. J Pak Med Assoc. 2019 Sep;69(9):1237-1241.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakil-ur Rehman principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy with distraction technique and conventional physical therapy with traction technique in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: 4th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393323, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.